The U.S. Food and Drug Administration (FDA) believes the medical devices called the Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits can cause unintended life-threatening injections of drugs and fluids into recipients.

What Is the Medtronic SynchroMed Implantable Infusion Pump?

Medtronic, an American medical technology company, developed at least two SynchroMed implantable infusion pumps. One is the SynchroMed II and the other is the SynchroMed EL, which Medtronic no longer sells. Physicians implant the devices in recipients’ lower abdomens underneath the skin, with one end of a catheter inserted into the intrathecal space in the spine and the other end connected to the device. Their purpose is to inject a predetermined amount of prescription painkillers into recipients’ spines at a preprogrammed rate or time. Both devices received FDA approval for injecting morphine, ziconotide, Lioresal (baclofen), floxuridine, and methotrexate. Medtronic has sold about 140,000 SynchroMed Implantable Infusion pumps worldwide.

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Physicians and recipients reported that the Medtronic SynchroMed devices cause “pocket fills” in recipients. The term “pocket” refers to the “pump pocket,” the place beneath the skin where the device is implanted. A pocket fill occurs when a physician refills the SynchroMed device and some or all of the drug inadvertently injects into the pump pocket rather than the device itself, which can result in drug under- or overdose. When Medtronic first became aware of the issue, it found that physicians were incorrectly placing the refill needle into the pump reservoir because they were judging successful needle insertion by hand. Between May 1996 and September 2010, eight deaths occurred and 270 more people suffered life-threatening injuries due to pocket fills.

On January 14, 2011, Medtronic sent an “Urgent Medical Device Correction” letter to physicians detailing proper insertion procedure. Then it went about the process of updating the SynchroMed devices’ and refill kits’ label information. In February 2011, the FDA classified Medtronic’s label changes as a Class I recall, meaning the FDA believes there is a reasonable probability that the use or exposure to the product will cause serious adverse health consequences or death.

On July 5, 2011, Medtronic sent a second Urgent Medical Device Correction letter to physicians, this time alerting them that a filmy substance could collect on the pump’s battery and cause sudden implant power loss. In these circumstances, the recipient received no injections of the prescribed painkillers, which in turn caused the return of pain and drug withdrawal symptoms. This letter only applies to SynchroMed II pump devices. Medtronic developed a new replacement battery for the SynchroMed II. Then, on August 29, 2011, the FDA again classified Medtronic’s Urgent Medical Device Correction letter a Class I recall, the second in one year.

Medtronic learned that physicians were prescribing unapproved medications with the Medtronic SynchroMed II and SynchroMed EL implantable drug infusion pumps. When dispensing approved drugs, the pumps’ 78-month failure rate is only 2.4 percent, but with unapproved drugs, the rate climbs to 7.0 percent. Medtronic notified health care professionals that using unapproved drugs can cause the pump motor to stall, ceasing drug infusion and leading to potentially life-threatening side effects. On November 9, 2012, the FDA classified Medtronic’s notification as a Class I recall.

On June 3, 2013, Medtronic sent two letters to health care providers, both dated May 2013, alerting them of two more adverse side effects that the two infusion pumps can cause. In one, Medtronic explained that there was a potential for electrical shorting in a feedthrough (a conductor on an electrical circuit board) that could stall the motor and lead to a life-threatening reduction in drug therapy. The second letter concerned the potential for the infusion pumps to deliver drugs at an unintentionally high rate during the “priming bolus procedure.” According to an article in Bloomberg, this procedure is “a function that allows drugs to move quickly from the pump to the tip of the catheter to deliver medication while the patient is under medical supervision.” Bothletters are considered Class I recalls by the FDA.

As of June 2013, fourteen patients implanted with the infusion pumps died as a result of adverse side effects. Eleven were due to pocket fills, two because of blockages, and one patient died because of an electrical short.

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The SynchroMed Implantable Infusion Pump lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a SynchroMed Implantable Infusion Pump lawsuit on your behalf if necessary. RLG will also keep you up to date on any SynchroMed Implantable Infusion Pump class action lawsuits, FDA SynchroMed Implantable Infusion Pump warnings, and new SynchroMed Implantable Infusion Pump FDA recall announcements. If you received Medtronic SynchroMed Implantable Infusion Pump and believe it harmed you, contact RLG today.

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